Marion woman sues pharmacy

Alleges negligence in pain meds

Published: Monday, October 15, 2012 at 5:41 p.m.

Last Modified: Monday, October 15, 2012 at 7:48 p.m.

OCALA - A Marion County woman has filed suit against the New England compounding pharmacy linked to the distribution of tainted pain medication.

Vilinda York is seeking more than $15,000 in damages from the pharmacy for pain and suffering. Her attorney, John Piccin, filed the lawsuit Monday in circuit court in Ocala.

York said she received two shots of tainted methylprednisolone acetate, a steroid used to treat back pain, in August. She suffers back pain because of a vehicle accident earlier this year.

She “became ill” after the shots and was hospitalized in September, the lawsuit says. She remains in hospital today for treatment of fungal meningitis.

State and federal officials say there are 10 Floridians diagnosed with fungal meningitis linked to the contaminated medicine. That count includes two deaths, both in Marion County.

The U.S. Centers for Disease Control and Prevention reported Monday that the number of confirmed cases of the rare form of meningitis rose to 214, including 15 deaths, in 15 states.

At least one other lawsuit — a federal action filed in Minnesota — has been filed. Meantime, there are calls for a Justice Department investigation and a review of the regulatory climate in which compounding pharmacies operate.

As all that plays out, the arduous task of trying to treat ill patients against a mostly unknown fungus is primarily being left up to local infectious disease physicians.

The disease is so rare that CDC officials admit that tests for the fungus causing the illness are not definitive. In many cases it can take weeks to get reliable results from body fluid samples.

Worse yet, there’s no conclusion among health experts how long the fungus remains in the body before symptoms show themselves, leaving thousands of people who received the contaminated injections frightened and doctors frustrated.

Nearly 130 people injected locally with the contaminated steroid manufactured by the New England Compounding Center (NECC) have gone to Marion County hospitals complaining of symptoms.

Dr. Ivan Soosaipillai of Ocala has seen as many as 40 of those patients.

The infectious disease doctor said he has never seen anything like this outbreak, and on this scale, during his career.

Soosaipillai said there is still so little known about the disease that it’s difficult to say how well patients are responding to treatment.

“We don’t know the nature of the beast yet,” he said of the disease.

In Florida, 775 doses of potentially contaminated vials have been injected into patients.

Soosaipillai has treated six of his patients with anti-fungal medicines: One died, one was taken to a hospital outside of Marion County by his family, and the remaining four are hospitalized in Marion.

“They (the latter four) are doing reasonably well, as in not getting worse. Stable,” Soosaipillai said.

But even that observation must be taken with a grain of salt, he said. Those four patients are showing fewer symptoms of the disease, which leads Soosaipillai to conclude the patients are getting better.

The treatment Soosaipillai uses is that recommended by the CDC.

Even the treatment has its own risks, involving potential kidney failure and liver poisoning.

“One of the patients had kidney issues (following treatment) but is recovering now,” he said.

But like so much else that’s unknown about the disease, Soosaipillai said he doesn’t know if the patient’s kidney problems were due to the treatment or the disease.

Soosaipillai isn’t alone with concerns of side effects of the treatment.

“These drugs are very strong and can be very difficult for patients to tolerate over a long period of time. We are working with our clinical experts to determine the best dose and the best length of time to treat patients,” said CDC Dr. J. Todd Weber during a news teleconference last week.

The second Marion County fatality, an 83-year-old man who died last week, was also Soosaipillai’s patient.

Asked whether the man died of fungal meningitis or from the side effects of the treatment, Soosaipillai replied, “It’s a difficult question to answer,” adding the patient had other medical problems.

Marion County’s first fatality due to the disease was unwittingly injected by Dr. Stephen Pyles of Ocala. Pyles contends the man did not die from meningitis, but rather from an unrelated stroke. The Florida Department of Health says the stroke was brought on by meningitis.

Also unknown is how long the patients will have to take the anti-fungal medicines and whether they’ll have to stay in the hospital.

“The onset of symptoms is typically between one and four weeks following injection. However, we want to emphasize that we know fungal infections can be slow to develop, and that there are indeed reports of longer periods of time between the injection and the onset of symptoms so patients and their doctors will need to be vigilant for at least several months following the injection,” Weber said.

What is known is that people who were injected by the contaminated steroid and get sick won’t be able to get healthy without medical help, Soosaipillai said.

“The body will not fight it off on its own,” he said, adding that patients left untreated could suffer complications such as paralysis.

NECC sent tainted lots to eight Florida clinics, including the three in Marion County. A total of 17,000 potentially contaminated vials were sent to 76 clinics in 23 states. An estimated 14,000 people might have been injected with the steroid, which is used to alleviate back pain.

All but one of Florida’s cases are in Marion County. The three local pain clinics that received the tainted lots were the Florida Pain Clinic, the Surgery Center of Ocala and the Marion Pain Management Center.

Pyles, who owns the Florida Pain Clinic, said far too little is known of the disease and the extent of contaminated vials for the CDC to draw conclusions about the outbreak.

<p>OCALA - A Marion County woman has filed suit against the New England compounding pharmacy linked to the distribution of tainted pain medication.</p><p>Vilinda York is seeking more than $15,000 in damages from the pharmacy for pain and suffering. Her attorney, John Piccin, filed the lawsuit Monday in circuit court in Ocala.</p><p>York said she received two shots of tainted methylprednisolone acetate, a steroid used to treat back pain, in August. She suffers back pain because of a vehicle accident earlier this year.</p><p>She “became ill” after the shots and was hospitalized in September, the lawsuit says. She remains in hospital today for treatment of fungal meningitis.</p><p>State and federal officials say there are 10 Floridians diagnosed with fungal meningitis linked to the contaminated medicine. That count includes two deaths, both in Marion County.</p><p>The U.S. Centers for Disease Control and Prevention reported Monday that the number of confirmed cases of the rare form of meningitis rose to 214, including 15 deaths, in 15 states.</p><p>At least one other lawsuit — a federal action filed in Minnesota — has been filed. Meantime, there are calls for a Justice Department investigation and a review of the regulatory climate in which compounding pharmacies operate.</p><p>As all that plays out, the arduous task of trying to treat ill patients against a mostly unknown fungus is primarily being left up to local infectious disease physicians.</p><p>The disease is so rare that CDC officials admit that tests for the fungus causing the illness are not definitive. In many cases it can take weeks to get reliable results from body fluid samples.</p><p>Worse yet, there's no conclusion among health experts how long the fungus remains in the body before symptoms show themselves, leaving thousands of people who received the contaminated injections frightened and doctors frustrated.</p><p>Nearly 130 people injected locally with the contaminated steroid manufactured by the New England Compounding Center (NECC) have gone to Marion County hospitals complaining of symptoms.</p><p>Dr. Ivan Soosaipillai of Ocala has seen as many as 40 of those patients.</p><p>The infectious disease doctor said he has never seen anything like this outbreak, and on this scale, during his career.</p><p>Soosaipillai said there is still so little known about the disease that it's difficult to say how well patients are responding to treatment.</p><p>“We don't know the nature of the beast yet,” he said of the disease.</p><p>In Florida, 775 doses of potentially contaminated vials have been injected into patients.</p><p>Soosaipillai has treated six of his patients with anti-fungal medicines: One died, one was taken to a hospital outside of Marion County by his family, and the remaining four are hospitalized in Marion.</p><p>“They (the latter four) are doing reasonably well, as in not getting worse. Stable,” Soosaipillai said.</p><p>But even that observation must be taken with a grain of salt, he said. Those four patients are showing fewer symptoms of the disease, which leads Soosaipillai to conclude the patients are getting better.</p><p>The treatment Soosaipillai uses is that recommended by the CDC.</p><p>Even the treatment has its own risks, involving potential kidney failure and liver poisoning.</p><p>“One of the patients had kidney issues (following treatment) but is recovering now,” he said.</p><p>But like so much else that's unknown about the disease, Soosaipillai said he doesn't know if the patient's kidney problems were due to the treatment or the disease.</p><p>Soosaipillai isn't alone with concerns of side effects of the treatment.</p><p>“These drugs are very strong and can be very difficult for patients to tolerate over a long period of time. We are working with our clinical experts to determine the best dose and the best length of time to treat patients,” said CDC Dr. J. Todd Weber during a news teleconference last week.</p><p>The second Marion County fatality, an 83-year-old man who died last week, was also Soosaipillai's patient.</p><p>Asked whether the man died of fungal meningitis or from the side effects of the treatment, Soosaipillai replied, “It's a difficult question to answer,” adding the patient had other medical problems.</p><p>Marion County's first fatality due to the disease was unwittingly injected by Dr. Stephen Pyles of Ocala. Pyles contends the man did not die from meningitis, but rather from an unrelated stroke. The Florida Department of Health says the stroke was brought on by meningitis.</p><p>Also unknown is how long the patients will have to take the anti-fungal medicines and whether they'll have to stay in the hospital.</p><p>“The onset of symptoms is typically between one and four weeks following injection. However, we want to emphasize that we know fungal infections can be slow to develop, and that there are indeed reports of longer periods of time between the injection and the onset of symptoms so patients and their doctors will need to be vigilant for at least several months following the injection,” Weber said.</p><p>What is known is that people who were injected by the contaminated steroid and get sick won't be able to get healthy without medical help, Soosaipillai said.</p><p>“The body will not fight it off on its own,” he said, adding that patients left untreated could suffer complications such as paralysis.</p><p>NECC sent tainted lots to eight Florida clinics, including the three in Marion County. A total of 17,000 potentially contaminated vials were sent to 76 clinics in 23 states. An estimated 14,000 people might have been injected with the steroid, which is used to alleviate back pain.</p><p>All but one of Florida's cases are in Marion County. The three local pain clinics that received the tainted lots were the Florida Pain Clinic, the Surgery Center of Ocala and the Marion Pain Management Center.</p><p>Pyles, who owns the Florida Pain Clinic, said far too little is known of the disease and the extent of contaminated vials for the CDC to draw conclusions about the outbreak.</p><p>“This situation changes almost hourly,” Pyles said. “The (CDC) really doesn't seem to know what they're dealing with.”</p><p>Pyles said he sent government health officials 120 of his unused vials that were part of the three recalled lots.</p><p>“No one will tell us whether any had any contaminant of any kind,” he said.</p><p>If his vials were not contaminated, he wants to share that news with his patients.</p><p>“It seems something is happening (with people getting sick),” he said. “But what I'm convinced of is that the CDC isn't sure what's going on.”</p><p><i>Contact Fred Hiers at fred.hiers@starbanner.com or 867-4157.</i></p>